Miltex Membrane Tack Kit
FDA 510(k) K092855 · Miltex, Inc.
510(k) numberK092855
Submission
- Device name
- Miltex Membrane Tack Kit
- Applicant
- Miltex, Inc.
York, PA, US - Received
- September 16, 2009
- Decision date
- December 29, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code DZL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254286 | Guided Bone Regeneration SystemDZL · Traditional | DentalMaster(Xiamen)Medical Technology Co., Ltd. | 08/24/2026SE |
| K250123 | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)DZL · Traditional | Hager& Meisinger GmbH | 09/29/2025SE |
| K251569 | Bone ScrewDZL · Traditional | Osstem Implant Co., Ltd. | 08/13/2025SE |
| K243190 | USTOMED Bone Fixation/Bone Augmentation Systems - PINDZL · Traditional | Ustomed Instrumente Ulrich Storz GmbH & Co. KG | 06/27/2025SE |
| K233419 | GBR SystemDZL · Traditional | Proimtech Saglik Urunleri Anonim Sirketi | 01/03/2025SE |
| K240321 | MP Pin flat without thread (36BMP000020/MP20)DZL · Traditional | Hager& Meisinger GmbH | 10/17/2024SE |
| K233721 | KLS Martin Drill-Free MMF ScrewDZL · Traditional | KLS-Martin L.P. | 09/17/2024SE |
| K231599 | Stryker MP, Mandible, HMMF and MMF AXS ScrewsDZL · Traditional | Stryker Leibinger GmbH & Co KG | 08/24/2023SE |
| K222367 | Save GBRDZL · Traditional | Dentis Co., Ltd. | 03/23/2023SE |
| K201210 | The Micro Screw System, Micro Screw System BasicDZL · Traditional | Hager& Meisinger GmbH | 10/08/2021SE |
More from Hager& Meisinger GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K101653 | Miltex Thompson Cassettes; Miltex Surgical CassettesKCT · Traditional | 08/02/2010SE |
| K083796 | Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex Self-Aspirating…EJI · Traditional | 03/09/2009SE |
| K072563 | Miltex Rigid Container SystemsKCT · Traditional | 02/12/2008SE |
| K061033 | Miltex Rigid Sterilization Container System, (47 Components)KCT · Traditional | 12/12/2006SE |
| K052018 | Miltex Ligating ClipFZP · Traditional | 11/04/2005SE |
| K050570 | Miltex Rigid Sterilization Container SystemKCT · Traditional | 07/25/2005SE |
| K043013 | Miltex Laparoscopic InstrumentsHET · Traditional | 03/04/2005SE |
| K013888 | Fixation (Steinmann) PinsHTY · Traditional | 05/01/2002SE |
| K954185 | Re-Bag Multi-Use Pouch, Large & SmallKCT · Traditional | 12/04/1995SESK |
| K823326 | Dental Instruments - Cutting InstrumentELA · Traditional | 11/24/1982SE |
Questions and answers
When was Miltex Membrane Tack Kit cleared by the FDA?
Miltex Membrane Tack Kit (K092855) received a 510(k) decision of Substantially Equivalent on December 29, 2009, 104 days after the submission was received.
What is the product code of K092855?
The FDA product code is DZL – Screw, Fixation, Intraosseous, a Class II (moderate risk) device regulated under 21 CFR 872.4880.